PHARMACOGENOMIC STUDY AIMED TO IDENTIFY A GENETIC PROFILE ABLE TO EARLY IDENTIFY RENAL TRANSPLANT RECIPIENTS AT HIGH RISK TO DEVELOP THE MAJOR ADVERSE EFFECTS ASSOCIATED WITH CERTICAN (EVEROLIMUS)

EXPLORATIVE STUDY TO IDENTIFY A SPECIFIC TRANSCRIPTOMIC PROFILE FOR PREDICTING THE MAJOR ADVERSE EFFECTS ASSOCIATED WITH CERTICAN (EVEROLIMUS) IN RENAL TRANSPLANT RECIPIENTS: A PHARMACOGENOMIC APPROACH - TREACE_2015

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004459-38-IT

Enrollment

Registered

2021-01-28

Start date

2016-02-24

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplant MedDRA version: 21.0 Level: PT Classification code 10038533 Term: Renal transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.0 Level: PT Classification code 10038533 Term: Renal transplant System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: CERTICAN - 60 COMPRESSE IN BLISTER ALU/PA/ALU/PVC DA 0.25 MG Product Name: certican 60CPR 0,25MG Product Code: 036373025 Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS Curren

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Informed consent • Age > 18 • First kidney transplant • patients treated with everolimus in combination with CNI (Ciclosporin or Tacrolimus) and corticosteroids Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Transplant of other organs associated with renal transplant • Active neoplasia (but not skin cancer non melanoma) • Acute and chronic hepatitis (hepatitis B, C) • Positive pregnancy test at the time of enrolment • Women in reproductive age without contraceptive method or breastfeeding women • HIV infection • hyperlipidemia/ Clotting problems • interstitial lung disease/ No infectious pneumonia

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To evaluate the differences in transcriptomic profile of peripheral blood mononuclear cells (PBMC) during the treatment of Everolimus in renal transplant recipients. We will perform transcriptomic analysis at the time of transplantation and after 3, 6, and 9 months post-transplant. The choice of this time period depends on the incidence of adverse effects caused by high dosage of maintenance immunosuppressive drugs.;Secondary Objective: 2.To study the relationship between gene expression and clinical data collected at any time point 3.To assess a specific correlation between gene expression and adverse effects (proteinuria, lymphedema, pulmonary toxicity) in order to obtain a transcriptomic biomarker able to early identify renal transplant recipients at high risk to develop adverse effects associated with Everolimus. This biomarker could be used by clinicians in order to personalize immunosuppressive therapy and reduce clinical complications 4.To study the biological pathway including the genes selected by transcriptomic analysis. The transcriptomic analysis will be performed on entire genome and for the subsequent analysis we will select only the genes strongly associated with adverse effects. ;Primary end point(s): To analyze the differences in transcriptome profiles from T0 to T3 ;Timepoint(s) of evaluation of this end point: (1 year)	—

Measure

Time frame

Main Objective: 1.To evaluate the differences in transcriptomic profile of peripheral blood mononuclear cells (PBMC) during the treatment of Everolimus in renal transplant recipients. We will perform transcriptomic analysis at the time of transplantation and after 3, 6, and 9 months post-transplant. The choice of this time period depends on the incidence of adverse effects caused by high dosage of maintenance immunosuppressive drugs.;Secondary Objective: 2.To study the relationship between gene expression and clinical data collected at any time point 3.To assess a specific correlation between gene expression and adverse effects (proteinuria, lymphedema, pulmonary toxicity) in order to obtain a transcriptomic biomarker able to early identify renal transplant recipients at high risk to develop adverse effects associated with Everolimus. This biomarker could be used by clinicians in order to personalize immunosuppressive therapy and reduce clinical complications 4.To study the biological pathway including the genes selected by transcriptomic analysis. The transcriptomic analysis will be performed on entire genome and for the subsequent analysis we will select only the genes strongly associated with adverse effects. ;Primary end point(s): To analyze the differences in transcriptome profiles from T0 to T3 ;Timepoint(s) of evaluation of this end point: (1 year)

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Secondary

Measure	Time frame
Secondary end point(s): 2. To study the relationship between gene expression and clinical data collected at any time point (2 years); 3. To evaluate differences in gene expression among patients with adverse effects (proteinuria, lymphedema, pulmonary toxicity) and patients with no adverse effects during 24 months (2 years); 4. To study biological pathways containing the genes selected in point 1, 2 and 3 (2 years). ;Timepoint(s) of evaluation of this end point: (2 years).	—

Measure

Time frame

Secondary end point(s): 2. To study the relationship between gene expression and clinical data collected at any time point (2 years); 3. To evaluate differences in gene expression among patients with adverse effects (proteinuria, lymphedema, pulmonary toxicity) and patients with no adverse effects during 24 months (2 years); 4. To study biological pathways containing the genes selected in point 1, 2 and 3 (2 years). ;Timepoint(s) of evaluation of this end point: (2 years).

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Countries

Italy

Contacts

Public ContactUnit¿ Supporto alla Ricerca e Biost

Unit¿ Supporto alla Ricerca e Biostatistica Azienda Ospedaliera Universitaria Integrata Verona

supporto.noprofit@ospedaleuniverona.it045-8127051

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026